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NCT Number: NCT05356611

Engage for Late-Life Depression and Comorbid Executive Dysfunction

Although there are an increasing number of mental health treatment adaptations for older adults, there are still a number of factors to consider when making these adaptations. Cognitive decline is one such factor that places significant burden on older adults and can interfere with traditional mental health therapies. Engage is a behavioral treatment approach that has shown to be effective in treating late life depression. The investigators are testing the feasibility of Engage as a treatment method for late life depression in older adults with cognitive decline. The objective is to corroborate Engage as an alternative late life depression treatment method for a sub-population of older adults with cognitive decline. Cognitive decline poses a unique mental health treatment barrier that is often over looked in younger populations. With a relatively higher prevalence of cognitive decline in older adulthood, it is imperative that a feasible mental health treatment program that can be effective in the presence of cognitive decline.

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Key information

Conditions

Depression in Old Age Cognition Disorders Cognitive Dysfunction Executive Dysfunction Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders Psychotherapy

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nevada

Las Vegas, Nevada, 89154, United States

Location status: Recruiting

Location contact

Brenna R Renn, PhD

CONTACT

[email protected]

702-895-0596

Matthew S Schurr, MA

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 60 or older
  • Ability to read, write, and speak English
  • Located in Las Vegas or surrounding area
  • Ability to travel to UNLV campus by self or possible caregiver for regular study visits
  • Clinically significant symptoms of depression as evidenced by: 1) Scores > 5 on the Geriatric Depression Scale-Short Form (GDS-SF)
  • Mild cognitive impairment as evidenced by: 1) Scores > 18 and < 25 on the Montreal Cognitive Assessment (MoCA)

Exclusion criteria

  • Active suicidal ideation
  • History of suicide attempt(s)
  • Current symptoms of: 1) Psychosis; 2) Active substance use disorder
  • Reported history of: 1) Bipolar disorder ("manic depression"); 2) Intellectual disability
  • Currently in or scheduled to initiate individual psychotherapy to avoid treatment interference
  • Psychotropic medication permitted if dose was stable over the past 2 weeks
  • Currently living in an institutional setting (e.g., assisted living, inpatient, skilled nursing)
  • Presence of notable memory-specific cognitive deficits as evidenced by: scores < 9 on the MoCA memory subscale (rendering it difficult to participate in and track/recall events for weekly psychotherapy)

Treatment and study plan

Engage

Behavioral

Engage is a 9-week, behavioral-based, psychotherapy treatment protocol for late-life depression.

Primary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.

    Measure of depressive symptoms used to assess changes across treatment from baseline to mid-treatment, to post-treatment, and follow up at 36 weeks post-baseline. Scores range from 0 - 54 with higher scores indicating worse depression.

Secondary outcomes

  1. World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Time frame: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.

    Measure of disability and functioning. Scores range from 0 to 100, with higher scores indicating worse disability.

  2. Behavioral Activation for Depression Scale (BADS)

    Time frame: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.

    Measure of behavioral activation (target mechanism). Scores range from 0 to 54, with higher scores indicating more dysfunction.

  3. Social Problem-Solving Inventory Revised-Short Form

    Time frame: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.

    measure of problem solving skills. Total scores range from 0 to 100. When all appropriate items are reverse-scored, higher scores indicate better social problem solving functioning.

Other outcomes

  1. Iowa Gambling Task - 2nd Edition

    Time frame: Baseline, Week 9, and Week 36 follow-up.

    Measure of reward response, decision-making and problem solving. Assess changes in target executive functioning skills across treatment. Produces multiple scores, generally with higher scores indicating better decision making.

  2. Hopkins Verbal Learning Memory Test-Revised

    Time frame: Baseline, Week 9, and Week 36 follow-up.

    Measure of memory. Assess potential changes in memory functioning across treatment. Consists of multiple trials and multiple ranges, with higher scores on each trial indicating better memory.

  3. Stroop Color-Word Interference Test

    Time frame: Baseline, Week 9, and Week 36 follow-up.

    Measure of processing speed and response inhibition. Assess changes in target executive functioning skills across treatment. Produces multiple scores across multiple trials and ranges, with higher scores indicating better performance.

  4. Trail Making Test A & B

    Time frame: Baseline, Week 9, and Week 36 follow-up.

    Measure of processing speed and set-shifting. Assess changes in target executive functioning skills across treatment. Time limited task, with higher time indicating worse performance.

Study contacts

Contact information is provided by the study sponsor or research team.

Brenna R Renn, PhD

CONTACT

[email protected]

7028950596

Matthew S Schurr, MA

CONTACT

[email protected]

7026957708

Sponsors and collaborators

Lead sponsor

University of Nevada, Las Vegas

Other

Registry information

Official study title

Engage: A Treatment for Late-Life Depression and Comorbid Executive/Cognitive Dysfunction

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 2, 2022
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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